FDA.reportPublic FDA data

RoyceDerm Seborrheic Scalp Spray-200

Manufacturer
RoyceDerm LLC
Effective date
2026-06-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-07-21 05:10:16

Label at a glance#

ProductRoyceDerm Seborrheic Scalp .spray.
Active ingredientSALICYLIC ACID
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Salicylic Acid 2.0%

OTC - PURPOSE SECTION

Anti-Seborrheic Dermatitis, Antidandruff

DOSAGE & ADMINISTRATION SECTION

  • controls the symptom of seborrheic dermatitis.
  • helps prevent recurrence of skin and scalp itching,irritation, redness, flaking, scaling associated with seborrheic dermatitis

WARNINGS SECTION

For external use only.

OTC - ASK DOCTOR SECTION

if you have a condition that covers a large area of the body.

OTC - WHEN USING SECTION

avoid contact with the eye. If contact occurs, rinse the eyes thoroughly with water.

OTC - STOP USE SECTION

Stop and ask a doctor if condition worsens or does not improve after regular use of this product as directed.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE SECTION

Adults and children 12 years & older:

  • apply to affected areas one to four times daily or as directed by a doctor.
  • spray directly onto the affected scalp area.
  • massage gently if needed.
  • do not rinse.

OTHER SAFETY INFORMATION

Store at room temperature and out of direct sunlight.

INACTIVE INGREDIENT SECTION

Water, Propanediol, Tromethamine,Butylene Glycol, PEG-40 Hydrogenated Castor Oil, Dipotassium Glycyrrhizate, Panthenol, Aloe Barbadensis Extract, Decyloxazolidi-none, Melaleuca Alternifolia (TeaTree) Leaf Oil, Laurylpyridinium Chloride, Glycerin, 1,2-Hexanediol,Crocus Sativus Flower Extract,Swertia Bimaculata Extract, Avena Sativa (Oat) Kernel Extract, Pullulan,Hydroxyacetophenone, Gentiana Scabra Extract, Gentiana Macrophyl-la Extract, Allantoin, Lavandula Angustifolia (Lavender) Oil, Citric Acid, Cyclodextrin, Niacinamide,Caffeine, Centella Asiatica Extract,Biotin, Hamamelis Virginiana (WitchHazel) Extract, Rosmarinus Officinalis (Rosemary) Extract.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

packagaepackagae

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130850082536610GTIN-13: 0850082536610
EAN-13: 0850082536610
GTIN-12: 850082536610
UPC-A: 850082536610
GTIN storage (14 digits): 00850082536610		package.jpg
QR code linkQR Codeqrco.de/bglweopackage.jpg

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 33 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85424-02885424-028-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 31 matching rows.

Name, UNII, Kind table
NameUNIIKind
MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OILVIF565UC2GIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
AVENA SATIVA (OAT) KERNEL OIL3UVP41R77RIACT
PANTHENOLWV9CM0O67ZIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
LAURYLPYRIDINIUM CHLORIDEKJM5A6A3YLIACT
SALICYLIC ACIDO414PZ4LPZACTIB
TROMETHAMINE023C2WHX2VIACT
NIACINAMIDE25X51I8RD4IACT
HYDROXYACETOPHENONEG1L3HT4CMHIACT
CITRIC ACID2968PHW8QPIACT
CAFFEINE3G6A5W338EIACT
CENTELLA ASIATICA LEAF WATERC4TH45M3K8IACT
PROPANEDIOL5965N8W85TIACT
PEG-40 HYDROGENATED CASTOR OIL7YC686GQ8FIACT
CROCUS SATIVUS FLOWER00IF91KFKQIACT
LAVANDULA ANGUSTIFOLIA (LAVENDER) OILZBP1YXW0H8IACT
ALLANTOIN344S277G0ZIACT
ROSMARINUS OFFICINALIS (ROSEMARY) LEAF OIL8LGU7VM393IACT
GENTIANA MACROPHYLLA ROOT6559FC0U1BIACT
ALOE BARBADENSIS LEAF JUICERUE8E6T4NBIACT
DECYLOXAZOLIDINONE95K9FHM51VIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
GENTIANA SCABRA WHOLE06T1X86LXTIACT
BIOTIN6SO6U10H04IACT
DIPOTASSIUM GLYCYRRHIZATECA2Y0FE3FXIACT
HAMAMELIS VIRGINIANA (WITCH HAZEL) LEAF WATER8FP93ED6H2IACT
CYCLODEXTRIN7E6SK9QDT8IACT
SWERTIA BIMACULATA WHOLEW00MO9Z07LIACT
PULLULAN8ZQ0AYU1TTIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RoyceDerm Seborrheic Scalp .spray.SALICYLIC ACID 2%RoyceDerm LLC55246263-7345-ba65-e063-6294a90ab1632026-06-26WarningsExact identifier
ndc (package): 85424-028-01
ndc (product): 85424-028
ndc11 (package): 85424002801
spl id: 55246263-7346-ba65-e063-6294a90ab163
spl set id: 55246263-7345-ba65-e063-6294a90ab163

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.